(a)Commencing January 1, 2027, a manufacturer of a bulk prenatal multivitamin product or a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state shall test a representative sample of each lot of the manufacturer’s bulk prenatal multivitamin product or packaged prenatal multivitamin product at a proficient laboratory for heavy metals.
(b)The proficient laboratory, including a manufacturer’s in-house laboratory, that analyzes the bulk prenatal multivitamin product or packaged prenatal multivitamin product for heavy metals shall meet all of the following criteria:
(1)
(A)Be accredited under the standards of the International Organization for Standardization’s (ISO) and the International Electrotechnical Commission’s (IEC) ISO/I
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(a)
Commencing January 1, 2027, a manufacturer of a bulk prenatal multivitamin product or a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state shall test a representative sample of each lot of the manufacturer’s bulk prenatal multivitamin product or packaged prenatal multivitamin product at a proficient laboratory for heavy metals.
(b)
The proficient laboratory, including a manufacturer’s in-house laboratory, that analyzes the bulk prenatal multivitamin product or packaged prenatal multivitamin product for heavy metals shall meet all of the following criteria:
(1)
(A)
Be accredited under the standards of the International Organization for Standardization’s (ISO) and the International Electrotechnical Commission’s (IEC) ISO/IEC 17025:2017 international standard regarding the general requirements for the competence of testing and calibration laboratories as they pertain to the testing of heavy metals.
(B)
To the extent such standards contradict the requirements of any federal regulations promulgated pursuant to the Federal Food, Drug, and Cosmetic Act pertinent to supplements, the federal regulations shall control.
(2)
Use an analytical method that is at least as sensitive and specific as that described in
Section 4.7 of the United States Food and Drug Administration’s Elemental Analysis Manual for Food and Related Products: Inductively Coupled Plasma-Mass Spectrometric Determination of Arsenic, Cadmium, Chromium, Lead, Mercury, and Other Elements in Food Using Microwave Assisted Digestion.
(3)
Demonstrate proficiency in quantifying each heavy metal to 10 micrograms or less of the
heavy metal to kilogram of supplement (μg/kg) through an independent proficiency test. Proficiency means that a laboratory achieves a z-score that is less than, or equal to, plus or minus two (≤ ±2).
(c)
Both manufacturers and brand owners shall provide test results to an authorized agent of the department upon their
request pursuant to Article 2 (commencing with Section 110140) of Chapter 2 or Article 11 (commencing with Section 111015) of Chapter 5. If a brand owner does not manufacture the bulk prenatal multivitamin product or packaged prenatal multivitamin product, they may comply with this subdivision by providing the test results of the manufacturer they use to produce the bulk prenatal multivitamin product or packaged prenatal multivitamin product.